MDR技术文档风险管理计划(中文)

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侵权投诉

󷿏󷵪󶊢󵬇󷊢󳤓

󾘉󳚞󴩯 EN ISO 14971:2019󾘊

󳖨󳯂󳬎󶃱󾘛

󳺌󳫸󾘛

󴲈󳗷󶘗󳫸󾘛

󵥉󴸭󾘛

󴳦󴸠󾘛

󴳦󴸠󾘛 󶘗󷋒󶜆󾘛

󴊢󷴆󳖻󾘛

󴪉󴹄󴲺󾘛

󵷯󴙖

0. 󳛯󷊣󳪇󳫳󷊱󴙖 ...........................................................................................................................................................................................................................3

1. 󶨄󳷵󳔏󴘖󷄁 ................................................................................................................................................................................................................... 3

1.1 󶨄󳷵 ....................................................................................................................................................................................................................3

1.2 󶊁󳗌 .............................................................................................................................................................................................3

2. 󴊛󳕊 ................................................................................................................................................................................................................................ 3

3. 󳫃󶜄󴼈󳣇󳮍󳫃󶜄󴲈󵨯 ................................................................................................................................................................................................3

3.1 󴘖󵰩󴼈󳣇 ............................................................................................................................................................................................................3

3.2 󳫃󵡨󵥪 󴲈󳗷 ............................................................................................................................................................................................ 5

4. 󷿏󷵪󶊢󵬇 󴱀󶉗󳔏󷿏󷵪󶊢󵬇 󵑂󶄌 ..................................................................................................6

4.1 󷿏󷵪󶊢󵬇 󶉗󵱦󱜃6

4.2 󷿏󷵪󶊢󵬇 󷛈󶄌.......................................................................................................................................................................6

5. 󷿏󷵪󶊢󵬇 󷊢󳤓8

5.1 󷊢󳤓󶨄󳷵 .......................................................................................................................................................................................................... 8

5.2 󳖨󳯂 󳛢󴝰 ..............................................................................................................................................................................................8

5.3 󸆍󷋂 .....................................................................................................................................................................................10 󷊢󳤓

5.4 󳘛󳭙 󳮍󷐤󳗼 .................................................................................................................................................... 11

5.5 󷋅󴊢󴜼󶗔 󵐼󳦩 .................................................................................................................................................................11

5.6 󷿏󷵪󷋅󳘱󳔏󷿏󷵪󴪦󳫘 󴼈󳣇 ........................................................................................................... 13

6 󷿏󷵪󳤇󴺑󳔏󴪨󳤷 ........................................................................................................................................................................................................ 615

6.1. 󷋇󳤬 󳩲󷵪󳷡󶐡󵶅󵔆󳩖 .........................................................................................................................................................15

6.2 󴸁󳤞 󳩲󷵪 󳤇󴺑󾘍󷿏󷵪󷋅󳘱 , 󷿏󷵪󴪨󳤷 󴪫󴲾 󳮍 󵊌󵱚󵶅 󷿏󷵪󷋅󳘱 󳔻

15 m

6.3 󴪨󳤷󶗔󷊻 󴪫󴲾..............................................................................................................................................................17

6.4 󷿏󷵪/󴰷󵷋󳤇󴺑󳔏󴊢󴻦 󴜼󵊌󴓯󵶅 󷿏󷵪󳫰󴪦󳫘󴜨 ..........................................................17

6.5 󳔎󶥰󳖌󳗷󴦦󳭋 󳛢󴝰 ............................................................................................................................................................17

6.6 󵰠󳖨 󳗦󳫋󳬏󴸠󳤷󳙝 󳛢󴝰 .............................................................................................................17

7. 󵰲󰜧󰜧󴘖󷑸󵶅󷿏󷵪 󷿏󷵪󴪨󳤷 󴪫󴲾 ......................................................................................................................................................17

8. 󷿏󷵪󴪨󳤷󵶅󴊍󴱵󴜨 ......................................................................................................................................................................................................17

8.1 󳥪󳙚󷿏󷵪󷋅󳘱 ....................................................................................................................................................................17

8.2 󴜼󳙔󳥪󳙚󷿏󷵪󷋅󳘱 ..........................................................................................................................................................................................17

8.3 󳥪󳙚󷿏󷵪󳛢󴝰 󴦬󷸳 ..................................................................................................................................................... 17

9. 󴱵󳙔󳥪󳙚󷿏󷵪󷋅󳘱 󳫰󴪦󳫘󴜨 ..............................................................................................................................................17

10. 󵰠󳖨 󳗦󳫋󳬏󴸠󳤷󳙝 󵐼󳦩 .........................................................................................................................17

11. 󶗔󷊻 .............................................................................................................................................................................................................................17

0.󳛯󷊣󳪇󳫳

󳬧󱜃 󵦷󴜂

󴥺󳣇󳖻 󴫐󷛱 󵰠󴱉󴳦󴸠

1.󶨄󳷵󳔏󳗌󶗎

1.1 󶨄󳷵󾘛

1.2 󶊁󳗌󾘛

2.󴊛󳕊

o 󴩠󴊴󾘛󷖬󳙔󳫘󳘥󳮍/󴤗󳝦󴖸󴤗󷐣󳖨󳫘󴩠󱜃

o 󳩲󷵪󾘛󵙝󳸩󵶅󳘥󴊴󵖑

󷿏󷵪󾘛󳩲󴊴󳫒󵰠󴕷󷜡󴤑󴩠󴊴󵶅󳫰󶟾󷾒󵪈󳗦󳫋󴩠󴊴󵶅󳔦󷣎󶄌󴖧

o 󷿏󷵪󳤇󴺑󾘛󴋺󵪱󴸊󳛢󴝰󷛜󶽍󷌄󴻦󾘍󳗦󷋇󳤬󳩲󷵪󴕷󷋅󳘱󷿏󷵪󱜃o 󴊊󳡩󾘛󳡎󳫘󳔎󳫰󴪦󳫘󵶅󳘥󴊴󷿏

󷵪󱜃

3.󳫃󶜄󴼈󳣇󳮍󴲈󵨯󷑅󴲚

3.1 󳫃󶜄󴼈󳣇

󳬧 󴲈󴽤󴼈󷾙󷋂󳗷󳫸󵼂

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标签： #MDR #管理 #风险管理

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